VALENCIA, Calif., Aug. 01, 2016 (GLOBE NEWSWIRE) — MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) appear it is now distributing MannKind-branded Afrezza® (insulin human) Assimilation Crumb anon to above wholesalers and that Afrezza is accessible by decree from retail pharmacies nationwide. The MannKind-branded artefact is associated with new Civic Drug Code (NDC) numbers, as acclaimed in the table below. With administering channels now stocked, the Company appear several key programs to advance access, acceptance and adherence to Afrezza therapy.
MannKind leveraged about two years of acquaintance apropos accommodating alternative and payor access, as able-bodied as new analytic abstracts and a bigger compassionate of how patients in the absolute apple administer their titration, to adviser its relaunch diplomacy for Afrezza. These diplomacy accommodate the afterward programs to enhance apprenticeship and uptake of Afrezza:
“Relaunching Afrezza as a MannKind cast is one of the best cogent milestones in our company’s history,” said Matthew Pfeffer, Chief Executive Officer of MannKind. “We are encouraged by the overwhelmingly absolute acknowledgment we accept accustomed from patients, physicians and advocates, who accept provided us with amazing acknowledgment on our relaunch of Afrezza, and whose inputs anon afflicted some of the programs appear today.”
While Afrezza is currently covered by bartering payers apery 70% of covered lives, abounding bloom diplomacy still crave a above-mentioned authorization. The MannKind Cares diplomacy will accumulate the accommodating and provider acquaintance about the above-mentioned allotment process, usually enabling patients to alpha on Afrezza aural days, and accept patients into a customized adherence program. This diplomacy will be accessible to physicians’ offices alpha the anniversary of August 8th.
MannKind additionally launched a new and bigger copay abetment program, which will abate the abroad amount to patients to as little as $15 per ages for commercially insured patients. With abroad costs continuing to be confused to patients, these programs are important to advice patients break on their analysis plans. The new copay agenda can be accessed on the Afrezza website, www. Afrezza.com. Above-mentioned copay cards activated with Sanofi will abide to be accustomed and accustomed by MannKind.
“Afrezza is a key analysis in the archetype about-face for insulin treatment, but with any above change in healthcare comes a charge for apprenticeship and abutment casework that access accommodating and physician awareness,” added Michael Castagna, Chief Bartering Officer of MannKind. “In accession to accumulating a best-in-class salesforce with abysmal accessory and diabetes experience, our new programs will advice accumulate and enhance the accommodating and provider acquaintance with Afrezza. The civic sales force began calling on targeted segments beyond the United States and Puerto Rico in aboriginal July.”
In affiliation with ablution the commercialization anatomy and programs, MannKind additionally appear the arrangement of Frank Pompilio, PharmD, as Vice President, of North America Medical Diplomacy advertisement to Chief Medical Officer, Dr. Raymond Urbanski. Dr. Pompilio has over 20 years of acquaintance in healthcare, pharmaceutical, and biotechnology industries. His best accepted position was Senior Director, Medical Communications at Allergan PLC, area he was amenable for the North American Medical Advice alarm center. Above-mentioned to the accretion of Kythera Biopharmaceuticals by Allergan in 2015, Dr. Pompilio was amenable for the development of the Medical Communications and Medical Advice functions at Kythera. Before Kythera, he served as Accurate Diplomacy Director and Inflammation Medical Communications Ameliorative Area Lead at Amgen Inc. and led a aggregation focused on the amalgam and advice of analytic and accurate abstracts in a counterbalanced and ethical address to appoint and brainwash the healthcare association with the ambition of optimizing accommodating care.
“Frank is an basic accession to our Analytic Development and Medical Diplomacy aggregation as we abide to body medical diplomacy capabilities and infrastructure,” said Dr. Raymond Urbanski. “He has actual albatross for MannKind’s medical science liaisons, all-encompassing out to key assessment leaders, managing our medical advice platform, and developing and active our Afrezza medical diplomacy strategy. I am aflame to accept Frank’s all-encompassing industry acquaintance at MannKind.”
INDICATIONPrescription Afrezza® (insulin human) Assimilation Crumb is a rapid-acting inhaled insulin acclimated to amusement adults with diabetes for the ascendancy of aerial claret sugar.
LIMITATIONS OF USEDo not use Afrezza as a acting for long-acting insulin; Afrezza charge be acclimated in aggregate with long-acting insulin in patients with blazon 1 diabetes.
Do not use Afrezza to amusement diabetic ketoacidosis.
Afrezza is not recommended in patients who smoke or who accept afresh chock-full smoking.
IMPORTANT SAFETY INFORMATION FOR AFREZZA
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
Do not use Afrezza if you accept problems with your lungs, such as asthma or COPD. Do not use Afrezza during a low claret amoroso acknowledgment (hypoglycemia). If you are allergic to any of the capacity in Afrezza, do not use Afrezza as this may account a cogent and astringent allergic reaction.
Before application Afrezza, your doctor will booty a medical history and do a concrete assay and a breath analysis (called spirometry) to actuate if you accept lung problems. Patients with lung problems should not use Afrezza. If your doctor finds you accept lung problems, use of Afrezza may account a astringent asthma-like breath problem. Afrezza can abate lung function, so your doctor will additionally appetite to analysis your breath 6 months afterwards starting Afrezza, and again anniversary year afterwards that, with added accepted testing done if you accept affection such as asthmatic or coughing. Acquaint your doctor if you currently accept lung blight or accept had it in the past, or if you accept an added accident of developing lung cancer.
You charge analysis your claret amoroso levels while application insulin such as Afrezza. Do not accomplish any changes to your dosage or blazon of insulin afterwards talking to your healthcare provider. Any change of insulin should be fabricated anxiously and alone beneath your doctor’s care.
The best accepted ancillary aftereffect of insulin, including Afrezza® (insulin human) Assimilation Powder, is low claret amoroso (hypoglycemia), which can be austere and life-threatening. Some bodies may acquaintance affection such as shaking, sweating, fast heartbeat, and blurred vision. It may account abuse to your affection or brain. It is important for you to accept how to administer the use of Afrezza, and to accept how to abate the accident of hypoglycemia events.
Tell your doctor about added medicines you take, abnormally ones frequently alleged TZDs (thiazolidinediones) and supplements, because they can change the way insulin works. If you accept affection abortion or added affection problems, it may get worse while you booty TZDs with Afrezza. Before starting Afrezza, it is important to acquaint your doctor about all your medical altitude including if you accept a history of lung problems, if you are abundant or plan to become pregnant, or if you are feeding or planning to feed.
In accession to low claret amoroso (hypoglycemia), added accessible ancillary furnishings associated with Afrezza accommodate cough, throat affliction or irritation, headache, diarrhea, tiredness, and nausea.Please see full Prescribing Advice for Afrezza, including Boxed WARNING and www.afrezza.com. ABOUT AFREZZA®Afrezza is a rapid-acting, inhaled insulin acclimated to ascendancy aerial claret amoroso in adults with blazon 1 and blazon 2 diabetes. The artefact consists of a dry conception of animal insulin delivered from a baby and carriageable inhaler. Administered at the alpha of a meal, Afrezza dissolves rapidly aloft assimilation to the lung and delivers insulin bound to the bloodstream. Peak insulin levels are accomplished aural 12–15 account of administration. Afrezza is accessible in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin crumb that can be used, as assigned by a bloom affliction professional, in aggregate with added diabetes medications to accomplish ambition claret amoroso levels. The disposable inhaler can be acclimated for up to 15 days, should be kept in a clean, dry abode with the advocate awning on and may be wiped with a clean, dry t if needed.
ABOUT MANNKIND CORPORATIONMannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) focuses on the analysis and development of ameliorative articles for patients with diseases such as diabetes. MannKind maintains a website at www.mannkindcorp.com to which MannKind consistently posts copies of its columnist releases as able-bodied as added advice about MannKind. Interested bodies can subscribe on the MannKind website to e-mail alerts that are beatific automatically back MannKind issues columnist releases, files its letters with the Securities and Exchange Commission or posts assertive added advice to the website.
FORWARD-LOOKING STATEMENTSThis columnist absolution contains advanced statements that absorb risks and uncertainties, including statements apropos MannKind’s adeptness to anon commercialize Afrezza and the bartering abeyant of Afrezza. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and agnate expressions are advised to analyze advanced statements. These advanced statements are based aloft the MannKind’s accepted expectations. Actual after-effects and the timing of contest could alter materially from those advancing in such advanced statements as a aftereffect of these risks and uncertainties, which include, afterwards limitation, the adeptness to accomplish cogent artefact sales for MannKind, MannKind’s adeptness to administer its absolute banknote assets or accession added banknote resources, banal amount animation and added risks abundant in MannKind’s filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year concluded December 31, 2015 and consecutive alternate letters on Form 10-Q and accepted letters on Form 8-K. You are cautioned not to abode disproportionate assurance on these advanced statements, which allege alone as of the date of this columnist release. All advanced statements are able in their absoluteness by this cautionary statement, and MannKind undertakes no obligation to alter or amend any advanced statements to reflect contest or affairs afterwards the date of this columnist release.
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